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QC Specialist

Location: Cambridge, Massachusetts Salary: competitive
Sector: Quality & Supply Chain Type: Contract

Our client in the pharmaceutical industry is seeking an experience QA Specialist to join their team on a long term contract at their Cambridge, MA location. This individual will be responsible for performing lot review/release activities for commercial drug substance, products and finished goods.

RESPONSIBILITIES:

  • Provide QA review and disposition of commercial lots of drug substance, drug product and finished goods
  • Distribute work to QA staff to assure timely review of batch documentation
  • Generate and/or review deviations and investigations to assess cGMP compliance of lots
  • Lead off-site visits and teleconferences for discussion and review of supplier performance to established schedules and cGMP compliance
  • Initiate, monitor and complete change controls related to Quality topcs
  • Review and approve supplier documents requiring Quality approval
  • Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, Process Validation protocols/reports as applicable
  • Provide training on department specific procedures and systems
  • Collect data, calculate, and report on departmental performance metrics Identify and propose Quality process and system improvements. Lead improvement projects
  • Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvements
  • Lead Investigation teams and ensure proper close out and follow-up
  • Review and approve process, assay, and other validation protocols and reports as applicable
  • Prepare and review applicable sections of regulatory submissions
  • Prepare and review applicable sections of the Annual Product Reviews

REQUIREMENTS:

  • BA/BS (or Master's) in any Life Science discipline preferred, and/or 8+ years experience in GxP Drug Manufacturing industry
  • Understands and applies good working knowledge of quality and GMP principles.
  • Ability to handle multiple tasks concurrently and in a timely fashion.
  • Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
  • Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint. Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
  • Must display eagerness to learn and continuously improve.
  • Positive work attitude that supports teamwork and continuous improvement.
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgement, intellectual honesty, pragmatism, courage and conviction.

Sthree US is acting as an Employment Business in relation to this vacancy.